Baraclude

Pronunciation

Generic Name: entecavir (en-TEK-a-vir)
Brand Name: Baraclude

Severe and sometimes fatal lactic acidosis (buildup of lactic acid in the blood) and liver problems have occurred with this type of medicine. The risk may be greater in women, in patients who are very overweight, or in patients who have been taking Baraclude or similar medicines for a long time. Patients with certain serious liver problems may also have a higher risk of developing lactic acidosis.

Some patients with hepatitis B virus (HBV) infection who took Baraclude had severe worsening of HBV infection after they stopped taking it. If you need to stop Baraclude, you will need close medical follow-up to check for worsening liver problems for at least several months after stopping it. Keep all doctor and lab appointments. Do not stop taking Baraclude without checking with your doctor.

Baraclude should not be used in patients who also have HIV infection and are not receiving highly active antiretroviral therapy (HAART). If you have HIV infection or think that you may have been exposed to HIV, talk with your doctor before you begin to take Baraclude.


Baraclude is used for:

Treating HBV infection in certain patients.

Baraclude is a nucleoside analogue. It works by reducing the amount of HBV in the blood. It also helps prevent the HBV from multiplying and infecting new liver cells.

Do NOT use Baraclude if:

  • you are allergic to any ingredient in Baraclude
  • you have HIV infection and you are not receiving HAART

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Baraclude:

Some medical conditions may interact with Baraclude. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have HIV infection or kidney problems, or if you are on dialysis
  • if you have a history of liver problems or you have had a liver transplant
  • if you are very overweight
  • if you have received medicine to treat hepatitis B in the past, or if you have been taking nucleoside analogues for a long time

Some MEDICINES MAY INTERACT with Baraclude. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Baraclude's side effects. Ask your doctor if you are unsure if any of your medicines may harm the kidneys.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Baraclude may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Baraclude:

Use Baraclude as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Baraclude. Talk to your pharmacist if you have questions about this information.
  • Take Baraclude on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal.
  • Baraclude works best if it is taken at the same time each day.
  • Continue to take Baraclude even if you feel well. Do not miss any doses.
  • If you miss a dose of Baraclude, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Baraclude.

Important safety information:

  • Baraclude may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Baraclude with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Baraclude does not stop you from spreading HBV to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have HBV infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors. A vaccine is available to protect people at risk from becoming infected with HBV.
  • Do not change your dose without checking with your doctor.
  • Baraclude is not a cure for HBV infection. Remain under the care of your doctor.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Baraclude, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • LAB TESTS, including liver and kidney function and HIV and HBV antibody, may be performed while you use Baraclude and for several months after you stop Baraclude. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Baraclude with caution in the ELDERLY; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Baraclude while you are pregnant. It is not known if Baraclude is found in breast milk. Do not breast-feed while taking Baraclude.

Possible side effects of Baraclude:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); symptoms of lactic acidosis (eg, fast or difficult breathing; fast or irregular heartbeat; feeling cold, especially in the arms or legs; severe dizziness or light-headedness; stomach pain with or without nausea or vomiting; unusual muscle pain; unusual weakness or tiredness); symptoms of liver problems (eg, dark urine, feeling sick to your stomach, pale stools, persistent loss of appetite, stomach pain, yellowing of the skin or eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Baraclude:

Store Baraclude in the original carton at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Baraclude out of the reach of children and away from pets.

General information:

  • If you have any questions about Baraclude, please talk with your doctor, pharmacist, or other health care provider.
  • Baraclude is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Baraclude or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Baraclude. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Baraclude. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Baraclude.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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